跳至主要内容
临床试验/NCT04788654
NCT04788654已完成3 期

The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月17日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Area under curve of postoperative pain for 24 hour

研究概览

简要总结

It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy

排除标准

  • Recent gastric ulcer disease
  • Hepatic or renal insufficiency
  • Opioid dependency
  • Coagulopathy
  • Pre-existing neurologic or anatomic deficits in the lower extremities
  • Severe psychiatric illness

研究组 & 干预措施

Pharmacological group

Active Comparator

Pharmacological analgesia will be performed

干预措施: Celebrex, acetaminophen, and dexamethasone (Drug)

Pharmacologican and surgical group

Experimental

Pharmacological and surgical analgesia will be performed.

干预措施: Celebrex, acetaminophen, and dexamethasone (Drug)

Pharmacologican and surgical group

Experimental

Pharmacological and surgical analgesia will be performed.

干预措施: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum (Procedure)

结局指标

主要结局

Area under curve of postoperative pain for 24 hour

时间窗: At postoperative 24 hour

Area under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).

次要结局

  • Analgesic requirements,(At postoperative 24 hour)
  • Postoperative pain score,(At postoperative 0, 2, 6, and 24 hour)
  • Sleep quality(At postoperative 24 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Do-Hyeong Kim

Associate professor

Gangnam Severance Hospital

研究点 (1)

Loading locations...

相似试验

Multimodal Analgesia for Cholecystectomy | 临床试验